LSC have a great contract opportunity for a Quality Assurance - Packaging to join a top 10 Pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Participate as functional expert in the cross functional team that manages production right first time.
- Review and approve batch, cleaning, graiand testing documentation.
- Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
- Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
- Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Contact Grainne Hodnett in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert!
